Government Sector Sr. In-House CRA

Emmes Group•Rockville, MD

12d

About The Position

The Senior In-House Clinical Research Associate (CRA) supports operational activities for site management and monitoring of clinical studies and trials. The role helps ensure that trials are conducted, recorded, and reported in accordance with study protocols, standard operating procedures, and applicable regulatory requirements. The Sr. In-House CRA may also support program-level status tracking and reporting across multiple studies and may be referred to as a Clinical Trial Associate on some contracts. Working under the high-level supervision of project site management staff, this role supports study teams and sites through essential-document management, regulatory submissions, progress tracking, training, issue resolution, and audit preparation. Depending on study needs, the role may also assist with monitoring visits, source-document review, clinical trial supplies, study documents, and DSMB meeting materials.

Requirements

Bachelor’s degree; a scientific discipline is preferred, or directly applicable work experience is preferred.
2–3 years of relevant clinical research experience, such as work as a CTA, in-house CRA, or study coordinator.
Proficiency with the MS Office Suite.
Excellent computer and organizational skills.
High attention to detail.
Ability to work on varying projects and exercise critical thinking.
Ability to work independently with limited oversight and collaborate cross-functionally as a self-starter and team player.
Knowledge of clinical research operations, including interpretation and implementation of country-specific regulations and ICH guidelines, as required.
Excellent oral and written organizational, interpersonal, and communication skills.
Demonstrated problem-solving skills, self-motivation, and adaptability in a dynamic environment.
Knowledge of prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities.
Ability to collaborate with internal and external colleagues and work well in a team-oriented setting.

Responsibilities

Triage questions and requests from site staff using working knowledge of the study protocol, site monitoring plan, and study manuals.
Collect, review, maintain, and track essential documents, assessing completeness, accuracy, good documentation practices, and regulatory and local requirements.
Upload essential documents into the trial master file.
Communicate and coordinate with internal project staff and site staff.
Complete IRB/EC submissions for sites or submit to a central IRB/EC on behalf of a site.
Update the Clinical Trial Management System and other software tools to provide trial progress tracking.
Provide mentorship and training to junior project staff.
Assist with audit preparation.
Assist the CRA with post-visit issue and action-item resolution and track action items through completion.
Track site training, recruitment efforts, and site screening logs.
Assist with database review to assess data currency and help site teams resolve data queries or discrepancies.
Review site-specific informed-consent language before submission to the IRB/EC.
Prepare and conduct training and retraining of site staff.
Prepare meeting agendas and minutes.
May assist in preparing study documents.
May assist with ordering clinical trial supplies from vendors, including laboratories and investigational product depots.
May assist experienced CRAs with remote or on-site qualification/pre-study, site initiation, interim/routine monitoring, closeout, and for-cause visits.
May perform remote review and monitoring of informed consent forms and other source documents.
May assist with preparation of DSMB meeting materials.
Perform other duties as assigned and comply with all policies and standards.